Navigation With X3 vs Non-Navigation With X3 Study

Stryker

Status: Completed

Conditions: Degenerative Joint Disease

Treatments: Device: Trident X3 Insert with conventional instrumentation; Device: Trident X3 Insert with Navigation system

Study type: Interventional

Funder types: Industry

Identifiers

NCT02543463

SJCR-OR-1101v2

Details and patient eligibility

About

The purpose of this study is to compare the effect of the large head in THA with a navigation system and without a navigation system.

Enrollment: 49 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient who is a candidate for a primary total hip arthroplasty (THA) with cementless acetabular and femoral components.
2. Patient who has a diagnosis of degenerative joint disease and no bacterial infectious disease.
3. Patient who is age 20 or over.
4. Patient who signed an Institutional Review Board (IRB)-approved, study specific Informed Patient Consent Form.
5. Patient who is willing to and able to comply with postoperative scheduled evaluations.

Exclusion criteria

1. Patient who has a bacterial infectious disease or has a high risk of a bacterial infection.
2. Patient who requires revision surgery of a previously implanted total hip arthroplasty.
3. Patient who is morbidly obese, defined as having a Body Mass Index (BMI) > 45.
4. Patient who is or may be pregnant female.
5. Patient who has neuromuscular or neurosensory deficiency, which limits ability to evaluate the safety and efficacy of the device.
6. Patient with diagnosed systemic disease (i.e. Paget's disease, renal osteodystrophy).
7. Patient who is immunologically suppressed or receiving chronic steroids.
8. Patient who is judged ineligible with specific reason by primary doctor.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

49 participants in 2 patient groups

With Navigation system

Other group

Description:

Large diameter head with Trident X3 insert with Navigation system

Treatment:

Device: Trident X3 Insert with Navigation system

Without Navigation system

Other group

Description:

Large diameter head with Trident X3 insert with conventional instrumentation

Treatment:

Device: Trident X3 Insert with conventional instrumentation